Clexane Forte 12,000 IU (120mg0/0.8ml Solution for Injection) with Eris needle guard safety system
*Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 March 2022
File name
ie clexane patient leaflet eris.pdf
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
Updated on 21 February 2022
File name
1.3.1 Clexane Patient Leaflet.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 21 February 2022
File name
1.3.1 SPC Clexane Forte 12,000 IU.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to restricted prescription (C)
Updated on 21 February 2022
File name
1.3.1 SPC Clexane Forte 12,000 IU.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 21 February 2022
File name
1.3.1 Clexane Patient Leaflet.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to restricted prescription (C)
Updated on 18 February 2022
File name
1.3.1 Clexane Patient Leaflet.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Updated on 18 February 2022
File name
1.3.1 SPC Clexane Forte 12,000 IU.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 12 October 2021
File name
1.3.1 SPC Clexane Forte 12,000 IU.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Updated on 12 October 2021
File name
1.3.1 Clexane Patient Leaflet.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
Updated on 18 February 2021
File name
clexane pl medicines 795296 new.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 06 July 2020
File name
1.3.1 Clexane patient leaflet 770581-WS100.pdf
Reasons for updating
- XPIL Removed
Updated on 27 May 2020
File name
1.3.1 SPC Clexane Forte 12,000 IU IE1091.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Sections 4.2, 4.4, 6.3 & 10 have been updated.
Updated on 27 May 2020
File name
1.3.1 Clexane patient leaflet 770581-WS100.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 12 August 2019
File name
Clexane Forte 12,000 IU (120 mg) 0.8 mL Solution for Injection in pre-filled syringes SPC.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to restricted prescription (C)
Updated on 24 January 2019
File name
PIL clexane dividella.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 06 September 2018
File name
1.3.2.1 Clexane Forte.pdf
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 June 2018
File name
Clexane Forte 12,000 IU (120 mg) 0.8 mL Solution for Injection in pre-filled syringes SPC.docx
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 1 added:-
In pre-filled syringes
Section 3 wording replaced with
Solution for injection in pre-filled syringes.
Clear, colourless to yellowish solution, pH value 5.5-7.5.
Section 4.2 removed:-
Note for the pre-filled syringes fitted with an automatic safety system: injection. (see instructions in section 6.6).
Section 4.8 formatting in section:- Blood and the lymphatic system disorders and Skin and subcutaneous tissue disorders
Section 6.2 wording replaced with:-
This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.
Section 6.4 refrigerate removed
Section 6.5 wording replaced with:-
Solution for injection in pre-filled syringes (type I glass) fitted with rubber stopper (chlorobutyl and bromobutyl) and injection needle (with automatic safety system ERIS™ or PREVENTIS™ or without an automatic safety system).
Supplied in packs of 2, 5, 6, 10, 20, 30, 50 pre-filled syringes and in multi-packs of 3 x 10 pre-filled syringes.
Section 6.6 wording replaced with:-
Pre-filled syringes are ready for immediate use. For method of administration see section 4.2.
Use only clear, colourless to yellowish solutions.
Pre-filled syringes are supplied with or without an automatic safety system. The instructions for use are presented in the package leaflet.
Each syringe is for single use only
Updated on 19 June 2018
File name
Clexane all strengths PIL.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 24 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 24 November 2017
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2017
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
6.5 - reference to 0/8ml and 1ml are removed in section 6.5.
Updated on 28 July 2017
File name
PIL_8364_792.pdf
Reasons for updating
- New PIL for new product
Updated on 28 July 2017
Reasons for updating
- Change to section 6 - marketing authorisation number
Updated on 17 May 2017
Reasons for updating
- Change due to harmonisation of SPC
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 16 May 2017
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 October 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 31 March 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 19 August 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 13 August 2014
Reasons for updating
- Change to side-effects
Updated on 17 July 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Type II.C.I.4 variation application to update safety information presented in sections 4.2 and 4.4of the SPC in line with current safety data presented in our Company Core Safety Data Sheet, version 12. The changes relate to concurrent use with spinal/epidural anaesthesia.
Updated on 08 January 2014
Reasons for updating
- Change of manufacturer
Updated on 07 January 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 18 December 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 19 September 2013
Reasons for updating
- Change of manufacturer
Updated on 08 January 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Type 1AIN B.II.e.6 Change in any part of the (primary) packaging material not in contact with the finished product formulation relating to below mentioned products.
Updated on 04 January 2013
Reasons for updating
- Change to dosage and administration
Updated on 27 November 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Type II variation related to significant modifications of the SPC due in particular to new quality, pre-clinical, clinical or phramacovigilance data.
Updated on 20 November 2012
Reasons for updating
- Change to information about pregnancy or lactation
Updated on 29 August 2012
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 08 March 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 23 September 2009
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 02 July 2009
Reasons for updating
- Change to MA holder contact details
Updated on 07 April 2009
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 13 May 2008
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to restricted prescription (C)
Updated on 05 March 2008
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 19 November 2007
Reasons for updating
- Changes to therapeutic indications
- Change to name of manufacturer
Updated on 21 March 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 13 March 2007
Reasons for updating
- Improved electronic presentation
Updated on 18 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 04 September 2006
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to restricted prescription (C)
Updated on 21 February 2006
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 08 February 2006
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to restricted prescription (C)
Updated on 24 June 2005
Reasons for updating
- Improved electronic presentation
Updated on 16 March 2005
Reasons for updating
- Change of manufacturer
Updated on 19 August 2004
Reasons for updating
- New PIL for medicines.ie